Critical Cleaning in Biotechnology

What Is Critical Cleaning In Biotechnology

Critical cleaning in biotechnology refers to a very specific type of cleaning in a highly regulated environment, where finished products (or validation tests) can be negatively affected if cleaning is not performed adequately.

Designing A Cleaning Program

There are several factors to consider when designing a cleaning program. Three key cleaning parameters include method, choice of detergent, and validation. As the cleaning process is designed, you should consider the appropriate residue-acceptance criteria, how to sample and analyze residue, and proper documentation that regulatory agencies may request.

Selecting Your Critical Cleaning Method

Cleaning methods vary based on the equipment being cleaned, type of soil, and required level of cleanliness. Common cleaning methods include clean in place (CIP), ultrasonic, manual, immersion, automatic systems, and pressure washing.

Small parts and equipment are often manually washed or put through an immersion washing system, while large equipment or a full apparatus may require a clean in place (CIP) method. Ultrasonic cleaning methods or automatic washing systems are often required for critical cleaning applications that need to be validated.

When developing a cleaning method, it is important to define the appropriate cleaning time, action, concentration, and temperature, which can vary based on the application, but are typically fixed in a controlled cleaning process.

Once you determine a cleaning method for your specific application, select the detergent best suited for your method and environment.

Selecting The Appropriate Detergent

Several types of critical cleaning detergents, such as MP Bio’s 7X Cleaning Solutions, are available to choose from, but not every detergent will be effective or appropriate for your specific piece of equipment or lab.

When selecting the detergent for your applications consider the soil to be cleaned, its compatibility with the surface or equipment to be cleaned, the specific cleaning method, and the impact of the detergent on the environment.

Ideal characteristics of a cleaning detergent include:

• Fast and effective removal of multiple soil types
• Rinses clean with no leftover residues
• Versatile for various surfaces
• Nontoxic for tissue and cell cultures
• Environmentally-friendly
• Concentrated so it is easy to dilute
• Lot-to-lot consistency

Our 7X cleaning solutions offer all of the characteristics above and more. Check out the 7X flyer to see if these products are a good fit for your critical cleaning needs.

How To Know If It Works

Robust validation programs are often required by regulatory agencies and enable efficient troubleshooting and process refinement. Establishing a reliable validation process involving appropriate sampling and analytical methods, acceptable residue limits, and regular monitoring are essential to the success of a cleaning program.

There are four common sampling methods to test for remaining active compounds (or degradation components) and for residue left by detergents:

• "Direct surface" sampling
• Swabbing
• Rinse-water sampling
• Placebo sampling

Sampling in biotech environments often involves rinse samples because the equipment is not always readily accessible for swab sampling. Also, you can use placebo sampling in the form of blank runs to assess total carryover throughout the entire process.

After sampling, you should use analytical methods that can reliably and reproducibly detect specific contaminants (e.g. active ingredients, degraded products, residual detergent, or analytes from prior runs). Because detergents often degrade active ingredients, testing for active ingredients alone does not necessarily reflect lingering contaminants, so multiple analytical methods may be necessary for cleaning validation.

Pro Tips

• Stay organized. Generate written sanitation procedures that include schedules, methods, and equipment materials for cleaning.
• Consider using automated equipment. Cleaning numerous pieces of equipment and glassware can be time consuming. A water purification system can reduce time spent cleaning equipment without sacrificing the level of cleanliness.
• Use a test kit, such as the CHEMetrics Kit, Hach Kit, or LaMotte Kit to test for residual detergent.
• Verify the performance of the cleaning process by conducting experiments in the pilot-plant or scale-up equipment to make adjustments to cleaning conditions.
• Establish change control, risk-based periodic monitoring, and data trending review in your validation process.